MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 8RSP003B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Itching Sensation (1943); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 12/20/2020

Event Type  Injury  

Event Description

I had synvisc injections in both knees on (b)(6) 2020.That afternoon i noticed a minor rash on my knees, shins, and arms.The rash was slightly itchy through (b)(6), but became more itchy on (b)(6).I used topical benadryl to ease the itch.On (b)(6) 2020 my knees began to ache, especially the left knee.On (b)(6) 2020 my upper calves and quads became really tight and stiff, making it difficult to do normal activities like walking my usual 4-5 miles/day, yoga poses (even simple ones like child's pose), and squatting down to pick something up.I was limping and barely able to take the dog for a walk around the block.Although i was able to ease into yoga poses, it really hurt, and squatting hurt to a point where i didn't want to do it but could force myself, despite the pain and stiffness.It was uncomfortable to sleep the night of (b)(6) 2020, and when i woke up on (b)(6) 2020 i could barely stand/walk/put weight on my legs, even with help from my husband.Both knees were very swollen and painful.I notified my doctor who aspirated both knees.The fluid analysis came back with inflammatory cells and no bacteria in either knee.I could barely walk with assistance from (b)(6) 2020 through (b)(6) 2021, and my knees and quads were quite painful (as was my back from having to hunch forward to shuffle walk).From (b)(6) 2020 - (b)(6) 2021 there was minimal, but gradual, improvement in my ability to stand and walk.My doctor aspirated my knees again on (b)(6) 2021.I iced them for several days afterwards and applied cbd/thc salve twice a day for two weeks.I also increased my dose of curcumin/tumeric to 500mg tumeric curcumin with bio-peperine 3x/per day to help with inflammation.I was able to drive for the first time on (b)(6) 2021, though it was challenging to get into and out of the car.I was able to walk 3 miles on flat surfaces on (b)(6) 2021, though with a limp.I couldn't go up and down the stairs until (b)(6) 2021 and i was walking with a limp through (b)(6) 2021 (21 days after the initial severe reaction).My knee tenderness didn't completely go away until (b)(6) 2021, and the swelling didn't completely go away until (b)(6) 2021.As of today ((b)(6) 2021) i have resumed most activities, but my knees are still not pain-free as they were before the synvisc injections and it's still challenging to hike and run.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 11342857
• MDR Text Key: 232892948
• Report Number: MW5099446
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/12/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2021
• Device Lot Number: 8RSP003B
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 51